MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was reported that bd posiflush plunger broke.The following information was provided by the initial reporter: plunger broke.The following information was provided by the initial reporter: we were able to recreate the malfunction with additional syringes from the same lot.Nurse reported that when she was drawing labs out of pt chemo port, the 10cc flush plunger broke while she was pulling back on the syringe to check for blood return.Multiple nurses then came forward saying this has been happening.Additional info: we were able to make the malfunction occur around 2 out of every 5 syringes.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The date received by manufacturer has been used for this field.
Event or Problem Description
3 sep 2024 customer response: was there any serious injury or harm to the patient related to the reported event? no harm noted.What was done to complete the treatment? a new syringe was obtained to withdraw the blood.
Additional Manufacturer Narrative
Additional information received: see b.Describe event or problem for details e/f codes updated.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot number 4015093.The review did not reveal any possible non-conformances during the product process that could have contributed to this incident.To aid in the investigation of this issue, one (1) syringe sample was returned for evaluation by our quality team.The sample was within the original blister package and was un-opened.Through inspection of the sample, no defects could be identified.Following the investigation results and based on the provided feedback, it was determined that the most probable cause for this incident was customer misuse.Posiflush syringes are pre-filled single use syringes, intended for flushing.Prefilled and conventional syringes have different purposes.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD POSIFLUSH
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20128336
• Report Number: 9616657-2024-00024
• Device Sequence Number: 20703638
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K153481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 306553
• Device Lot Number: 4015093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided; 09/23/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/11/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown